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Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions (SCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01621893
Recruitment Status : Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health.

Condition or disease Intervention/treatment
Bone Marrow Edema Procedure: Subchondroplasty

Detailed Description:
This study is designed as a prospective, consecutive series outcomes study. Patients presenting with knee pain associated with bone marrow lesions that meet the inclusion criteria will be eligible to undergo Subchondroplasty procedure. The subjects will be followed for twenty-four (24) months after surgery via office visits and will be contacted once per year for up to 5 years post-operatively and asked questions regarding their pain and functioning to further understand long-term outcomes.. Seventy (70), a ( minimum of sixty-two (62)) patients who meet the inclusion/exclusion criteria will be enrolled in the study. Up to 5 sites will participate in this study. The study is intended to provide an estimate of one-year and two-year clinical success with minimum bias and with sufficient statistical precision to permit meaningful comparison to commonly accepted two-year clinical success rates for currently available treatment alternatives. An improvement of 10 points on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscore on the KOOS Scoring System from baseline to 1-year post-operative is considered minimal perceptible clinical improvement and will be used to define the primary clinical success criterion for this study.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Efficacy Evaluation of Subchondroplasty™ for the Treatment of Defects Associated With Tibial Bone Marrow Lesions
Actual Study Start Date : March 26, 2012
Actual Primary Completion Date : January 17, 2018
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
BML of the Knee
Subject has single bone marrow lesion of tibia, single BML of femur, or adjoining BML's of tibia & femur on which a Subchondroplasty procedure is performed
Procedure: Subchondroplasty
Other Name: Calcium Phosphate Bone substitute filling of micro fractures




Primary Outcome Measures :
  1. Knee Injury Osteoarthritis Outcomes Score (KOOS) Pain Subscore [ Time Frame: 1 Year ]
    Post-operative KOOS pain subsection score at 1-Year follow-up is improved by at least 10 points. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale


Secondary Outcome Measures :
  1. Improvement from baseline in KOOS subsection scores [ Time Frame: 24 Months ]
    The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, activities of daily living (ADL), function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale.

  2. Improvement in VAS [ Time Frame: 24 Months ]
    The VAS is a validated pain scale. Subjects are asked to rate the amount of pain they have experienced with activity (walking, climbing stairs) for the past week by placing a slash through a 100mm line, which bests describes the pain when 0 is no pain and 100 is worst pain imaginable. Study personnel will measure where the subject placed the mark and transcribe this on an eCRF.

  3. Improvement in Modified Knee Score [ Time Frame: 24 Months ]
    Subjects will be asked to complete the Modified Knee Score pre-operatively and at each follow-up visit. The Modified Knee Score is a validated questionnaire composed of 4 questions to evaluate pain and function primarily before and after knee arthroplasty. The score is based on a maximum 100 points with Excellent = 85-100; Good = 70-84; Fair = 60-69; Poor = <60

  4. Improvement in IKDC [ Time Frame: 24 Months ]
    The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. A score of zero is the lowest level of function or highest level of symptoms to 100, highest level of function and lowest level of symptoms.

  5. Maintenance or improvement in usage (i.e., reduction in usage) of NSAIDs, narcotics, anti-inflammatory medications [ Time Frame: 24 Months ]
    Subjects will be asked pre-operatively what medications are taken as part of their knee treatment and at each follow-up visit, medications taken or currently taking as part of their recovery

  6. Complications or secondary procedures at index site of knee [ Time Frame: 24 Months ]
    Incidence of secondary or revision procedures will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with single bone marrow edema of the tibia, single bone marrow lesion of the femur or adjoining bone marrow lesions of the tibia and femur (kissing lesions).
Criteria

Inclusion Criteria:

  • Subject is 40-70 of age and skeletally mature
  • Subject BMI is < 40
  • Subject has experienced pain in knee for at least 3 months
  • BML is confirmed on T2 weighted MR Imaging by presence of white signal
  • Subject has single BML of tibia, single BML of femur, or adjoining BML's of tibia & femur
  • Baseline KOOS pain subscore is ≤65
  • Subject's involved knee alignment is defined radiographically as one of the following: Neutral, ≤ to 7 degrees mechanical varus or < 7.5 degrees mechanical valgus
  • Subject's ACL and PCL ligaments are intact
  • Subject has failed no more than one operative treatment on treatment knee, and none within 6 months prior to enrollment
  • Subject is willing and able to sign a written consent form
  • The subject has the mental capacity and the willingness to comply with the specified follow-up evaluations, and can be contacted by telephone by the site personnel.

Exclusion Criteria:

  • Surgeon deems subject's pain to be primarily related to an alternate condition such as a baker cyst, synovitis, meniscal pathology, or other
  • BML caused by acute trauma
  • Subject is not neurologically intact (sensory, motor, and reflex deficit)
  • Subject is insulin dependent
  • Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years
  • Subject with primary bone tumor in the knee area
  • Subject anticipates having a lower extremity surgery other than the investigational surgery during the course of the study
  • Subject has a history of substance abuse
  • Subject is currently involved in another study or have received investigational product or treatment within the last 30 days
  • Subject is pregnant or planning on becoming pregnant during the study period
  • Subject is accepting workers' compensation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621893


Locations
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United States, California
CORE Orthopaedics
Encinitas, California, United States, 92024
United States, Illinois
Hinsdale Orthopedics
New Lenox, Illinois, United States, 60451
United States, New York
Hospital for Joint Disease
New York, New York, United States, 10003
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Allegheny Orthopaedic Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Steadman Hawkins Foundation
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Steven Cohen, MD Rothman Institute

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01621893    
Other Study ID Numbers: KC-SCP-001
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Zimmer Biomet:
bone marrow edema
bone marrow defects
Additional relevant MeSH terms:
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Edema
Signs and Symptoms